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OSTEOPOROSIS OROR OR Towards a Fracture-Free Future March, 2011
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OSTEOPOROSIS

OROR OR

Towards a Fracture-Free Future

March, 2011

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Patientswithfragilityfracturesareatthehighestriskofdevelopingnewfractures.Interventionscanreducethatrisk!

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Executive Summary

The Problem: Post-Fracture Care Gap

Hundreds of thousands of Canadians needlessly fracture each year because their osteoporosis goes undiagnosed and untreated.

Key Considerations:

Over 80% of all fractures after age 50 are caused by osteoporosis. Despite availability of BMD testing and coverage for osteoporosis medications, over 80% of fracture patients are never offered assessment and/or treatment for osteoporosis post fracture.

Without appropriate diagnosis and treatment, these patients remain at substantial risk for recurrent, debilitating and life threatening osteoporotic fractures.

Spine and hip fractures are associated with an increased risk of death within the first year post fracture1, 2. Long term pain and disability are all too frequent. The fear of falling results in seclusion, isolation and depression.

The risk of a major osteoporotic fracture in Canada is among the highest in the world (in the top quarter). Each year 30,000 Canadians break their hip. This is just the tip of the iceberg: many more Canadians suffer osteoporotic fractures affecting the spine, wrist, shoulder, and pelvis.

The cost to the Canadian health care system of treating osteoporotic fractures is currently estimated to be $1.9 billion annually. The annual economic impact of hip fractures alone is projected to rise to $2.4 billion annually by 20413.

At least 15-25% of hip fracture patients require admission to a nursing home, thus contributing to the long wait times for nursing home beds4, 5. By consuming scarce orthopaedic resources, hip fractures contribute significantly to the long wait times for hip and knee replacement surgery.

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The Voice of Canadians:

Osteoporosis patients have spoken. The newly released Osteoporosis Patient Bill of Rights6 demands that the post fracture care gap be addressed.

Osteoporosis Canada’s Scientific Advisory Council, with input from osteoporosis experts from across the country, published updated Clinical Practice Guidelines (October 2010)7 which address the post fracture care gap and make recommendations on cost effective solutions. Coordinated post fracture care programs using Case Management are recommended as the most cost effective programs in reducing fractures rates, including devastating hip fracture rates.

Current Status:

In Ontario, Case Managers facilitate diagnosis of osteoporosis in patients who attend high and medium volume fracture clinics. This approach alone is not easily accessible for spine and hip fracture patients who do not usually receive care through Ontario’s out-patient fracture clinics.

There are no coordinated post fracture care programs in other Canadian provinces.

The Solution:

Patients with hip, spine and other osteoporotic fractures need appropriate assessment and treatment for their underlying osteoporosis. What Canada needs now are coordinated Post Fracture Care Programs with Case Managers to effectively identify and manage these patients – so that their first fracture will be their last.

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The Problem

Osteoporosis – More Frequent Than the Big Three Osteoporotic or fragility fractures are extremely common8, more common than heart attack9, stroke9 and breast cancer10 combined. At least one in three women and one in five men will suffer from an osteoporotic fracture during their lifetime11-14.

Osteoporosis – Worse in Canada than in Most Countries The risk of a major osteoporotic fracture in Canada is among the highest in the world (in the top quarter). Each year 30,000 Canadians break their hip. This is just the tip of the iceberg: many more Canadians suffer osteoporotic fractures affecting the spine, wrist, shoulder, and pelvis

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Osteoporosis – Impact on Mortality Osteoporosis is not a benign disease. Both spine and hip fractures result in an increased mortality rate1, 2. Twenty-eight percent of women and 37% of men who suffer a hip fracture will die within the following year15.

Osteoporosis – Impact on Quality of Life

The effects of osteoporotic fractures are devastating. For those who suffer wrist, spine, shoulder, hip and other osteoporotic fractures, the stories are personal ones – heartbreaking accounts of chronic pain, fear, loss of freedom and long-term disability. One-quarter of hip fracture patients who survive will still not have regained their mobility, even one year after having fractured 16.

Loss of height and kyphosis (curvature of the upper back) diminish self-esteem. The very real fear of falling, especially during Canadian winters, results in extreme limitation of activities. This can lead to isolation from the community, from family and from friends and can result in depression, especially in the elderly. Osteoporosis – Burden on the Family Osteoporotic fractures place a significant burden on family caregivers who are often required to give up their jobs and assume additional responsibilities as a result of their loved one’s decreased mobility and disability.

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Osteoporosis – Cost to the Health Care System The impact of osteoporosis on the health care system and the cost to society are substantial. Osteoporotic fractures have been associated with an increased length of hospital stay and with increased rates of institutionalization4, 17. A Canadian study of 18 different health conditions showed that hip and vertebral fractures were among the top three conditions responsible for extended hospital stays and substantial health care costs18. Osteoporotic hip fractures consume more hospital bed days than stroke, diabetes, or heart attack. Only 44% of people hospitalized with a hip fracture are discharged home. Of the remainder, 10% go to another hospital, 27% go to a rehabilitation centre and 17% go to long-term care facilities4.

Additional Canadian research done looking at 1998 data showed that after a hip fracture, a patient who returned home within the first year cost the health care system in excess of $21,385 in direct costs, while a patient who needed to be institutionalized after hospitalization cost over twice as much at $44,1563. The Canadian health care system currently pays an estimated $1.9 billion annually to treat the many osteoporosis related fractures. With the aging population, the annual cost of hip fractures alone is projected to rise to $2.4 billion annually by 20413.

Hip fractures consume scarce orthopaedic resources. Osteoporotic fractures significantly contribute to the long wait times for hip and knee replacement surgery. Fifteen to twenty-five percent of hip fracture patients end up in long term care facilities4, 5 and contribute to longer wait times for nursing home beds.

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Osteoporosis – Burden of Repeat Fractures Once an osteoporotic fracture has occurred, another is more likely to occur in the absence of treatment19. A Canadian study showed that 14% of persons with a wrist fracture suffered a repeat fracture within 3 years20. One in three hip fracture patients re-fracture at one year and over 1 in 2 will suffer another fracture within 5 years 21. The risk of suffering a second spine fracture within the first 12 months following an initial vertebral fracture is 20%22.

There is no doubt that fracture patients represent a population which is at extremely high risk to re-fracture – if left untreated. Identification and treatment of osteoporosis at the time of the initial fracture can significantly reduce this risk and the associated costs of repeat fractures.

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The Care Gap

Osteoporosis – Surprisingly Undertreated in Canada In most provinces, the vast majority of men and women presenting at Canadian hospitals with fragility fractures are neither screened nor treated for their underlying osteoporosis to prevent future fractures. A huge care gap exists after a fracture. Despite the availability of BMD testing and coverage of osteoporosis medications by provincial public drug plans, recent Canadian data indicates that over 80% of fracture patients are never offered screening and/or treatment for osteoporosis post fracture 23, 24. This is in sharp contrast to the rate of treatment post heart attack25 as shown by the graph below:

Without appropriate diagnosis and treatment, these patients remain at substantial risk for recurrent, debilitating and life threatening osteoporotic fractures.

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Canadian Osteoporosis Patients Have Spoken The Canadian Osteoporosis Patient Bill of Rights6, released in October 2010, states: “We believe that every Canadian who has sustained an osteoporotic fracture has a right to:

Timely care and treatment including adequate pain control; Be assessed for future fracture risk and where appropriate offered effective

treatment to prevent more fractures; Be assessed for falls risk and where appropriate provided access to falls

prevention tools and resources; and Education about osteoporosis and strategies to help reduce their risk of future

fractures.”

Canadian fracture patients are demanding that the post fracture care gap be closed.

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The Solution

Osteoporosis Canada has Published New Evidence Osteoporosis Canada has published updated Clinical Practice Guidelines (October 2010)7 which address the post fracture care gap and make medical recommendations on cost effective solutions (see Appendix B). Two areas that can significantly improve osteoporosis outcomes for fracture patients include: Bone Mineral Density (BMD) Testing

Patient awareness and understanding of BMD test results increases osteoporosis treatment rates and patient adherence to treatment 26, 27

Osteoporosis Medications

Effective medications reduce subsequent fractures by 30% to 70% as early as one year after initiation of treatment7, 28-42.

The Missing Piece In Canada, the provincial infrastructure required to appropriately manage fracture patients is already in place: Bone Mineral Density (BMD) testing – is an integral part of a comprehensive

fracture risk assessment. BMD units are available in all provinces. Osteoporosis medications – several inexpensive options that are effective at

reducing fracture risk are already accessible.

However, the key challenge lies in the fact that most fracture patients never receive BMD testing - nor will they be prescribed effective osteoporosis medications. The missing piece? In most Canadian provinces there is no coordinated strategy which links fracture patients with the services that already exist. Canadian provinces need system-wide and effective screening and post fracture care strategies for the identification and treatment of high fracture risk patients.

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Chipping Away at the Fracture Pyramid

To achieve the most dramatic reduction in future fracture rates and orthopaedic health care costs, Canada must first target those patients who have already fractured because they are the ones at highest risk for more fractures.

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Interventions That Work In recent years, much research has been invested in the development of strategies that will improve the post fracture care gap. Only a Case Management approach has been consistently shown to significantly improve the post fracture care gap43-51. Case Managers can target a patient’s health care needs and coordinate multiple services from multiple providers. Our complex and fragmented health care system creates formidable obstacles for older, disabled patients and their families. For the fracture patient, a Case Manager is the link between the patient, the orthopaedic surgical team and those services that exist to manage osteoporosis.

Case Managers, also known as Fracture Liaison Nurses or Fracture Coordinators, are individuals whose sole responsibility is to flag fracture patients for appropriate intervention. Case Managers:

identify fracture patients within the health care system (via fracture clinics, orthopaedic surgical wards or electronic medical records)

ensure that fracture patients receive appropriate BMD testing

provide access to education, including nutritional counselling, exercise and fall prevention, all of which reduce future fractures

communicate with primary care providers to ensure the fracture patient receives effective osteoporosis medications to prevent future fractures.

Case Management has been shown to improve the care of fracture patients by as much as 80%. Such programs reduce the incidence of future fractures including costly hip fractures. The end results are highly cost-effective45, 46, 49, 52, 53. In the evidence-based 2010 Clinical Practice Guidelines for the Diagnosis and Management of Osteoporosis7, Osteoporosis Canada,states that “Case management is recommended as an effective approach to post fracture care, to improve both the diagnosis and the management of osteoporosis.” These Guidelines have been endorsed by 12 Canadian professional organizations (see Appendix C).

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Interventions that Have Worked for Other Countries Many effective models of Case Management following fracture have been implemented internationally43, 49. Such programs significantly reduce the incidence of further fractures, including costly hip fractures, and demonstrably reduce future costs. The savings from the reduction in the incidence of hip fractures alone have more than offset any additional costs to the program from the increased number of BMD tests performed and osteoporosis medications prescribed49, 53. The Canadian Experience So Far Case Management is not only clinically effective, it is also cost effective. In a pilot project in Alberta, Case Managers for hip fracture patients operated at an average cost of $56.00 per patient. A cost effectiveness analysis showed savings for the Alberta health care system of an average of $2,476 per patient by reducing future health care costs associated with repeat fractures52. A similar program at St. Michael’s Hospital in Toronto showed that one Case Manager can prevent an average of 3 hip fractures per year. The net cost savings to the hospital was $48,950. This Case Management program covered all of the costs of the Case Manager and more45. Based on the St. Michael’s Hospital model, the Ontario Ministry of Health and Long Term Care has been operating an effective Post Fracture Screening Program since July 2007. This program focuses on the needs of out-patients seen in fracture clinics who suffered a wrist and other osteoporotic fractures. However this approach alone is not easily accessible for spine and hip fracture patients who do not usually receive care through Ontario’s out-patient fracture clinics.

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What Canada Needs Now

The vast majority of patients who fracture are never assessed or treated for their underlying osteoporosis. They just fall through the cracks in the current health care system and they fracture again and again. What Canada needs now are coordinated Post Fracture Care Programs with Case Managers to effectively identify and manage these patients – so that their first fracture will be their last. Case Managers can ensure….

that fewer Canadians will suffer a fracture. This will be the first step TOWARDS A FRACTURE-FREE FUTURE for Canada.

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Appendix A

About Osteoporosis Canada

Established in 1982, Osteoporosis Canada (OC) was the first national organization for osteoporosis in the world and is the only national charitable organization serving Canadians who have, or are at risk of, osteoporosis. OC works to educate, empower and support individuals and communities in the risk reduction and treatment of osteoporosis.

Vision

Canada without osteoporotic fractures.

Mission

To work towards a future where all Canadians will: be knowledgeable about osteoporosis be empowered to make informed choices about their bone health have access to the best osteoporosis care and support benefit from research into the prevention, diagnosis and treatment of osteoporosis.

Top Strategic Priority

Focus on Highest Risk Patients (those who have already fractured)

Contact Information

Osteoporosis Canada 1090 Don Mills Road, Suite 301 Toronto, Ontario M3C 3R6 1-800-463-6842 (English) 1-800-977-1778 (French) www.osteoporosis.ca For further information, contact the National Advocacy Co-Chairs:

Marg MacDonell, [email protected] Dr. Diane Thériault, [email protected]

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Appendix B

2010 Osteoporosis Canada Clinical Practice Guidelines

Osteoporosis Canada’s 2010 Clinical Practice Guidelines for the Diagnosis and Management of Osteoporosis of Canada7 makes evidence based recommendations to decrease the risk of fractures in the Canadian population. Many of its recommendations are focused on the care of fracture patients. These recommendations have significant and timely implications for our health care system. Osteoporosis Diagnosis: It is recognized that a fragility fracture in and of itself confers a very significantly increased risk of re-fracture. A fragility fracture is an important warning sign that cannot be ignored. It should flag the individuals for osteoporosis screening and possible treatment. Given this, the new Guidelines recommend a comprehensive approach to fracture risk assessment to include incorporation of key clinical risk factors such as prior fractures. Some key recommendations of the new Guidelines include:

Individuals 50 years and older who have experienced a fragility fracture should be assessed and considered for treatment.

Prior fragility fracture of spine or hip are considered very high risk situations and these patients warrant institution of an effective osteoporosis medication, irrespective of BMD.

Individuals over age 50 with two or more prior fragility fractures are considered at very high risk and warrant institution of an effective osteoporosis medication, irrespective of BMD.

A fragility fracture after age 40 must be incorporated as an additional risk factor when BMD test results are used to determine a person’s comprehensive risk of fracture.

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Osteoporosis Treatment: The goal of treatment post fracture is to reduce a person’s risk of re-fracture. Consequently, medications which have proven fracture reduction benefits should be the first choice for osteoporosis management. Having reviewed the evidence for fracture reduction benefit of osteoporosis medications, the 2010 Guidelines make the following recommendations which apply to fracture patients:

Fragility fracture of the hip or spine, or more than one fragility fracture event, constitutes a high risk for future fracture and such individuals should be offered pharmacologic therapy.

For menopausal women requiring osteoporosis treatment: o Alendronate, denosumab, risedronate, and zoledronic acid can be used as

first-line therapies for prevention of hip, non-vertebral, and vertebral fractures. (For women with menopausal symptoms, hormone replacement therapy is another alternative.)

For men requiring osteoporosis treatment: o Alendronate, risedronate, and zoledronic acid can be used as first-line

therapies for prevention of fractures.

Special Recommendations for Health Policy Makers: Closing the post fracture care gap will require more than just educating patients and health care professionals on the best practices for post fracture care. It will necessitate some attention/action by policy makers. Some changes in the current health care system are recommended:

Case management is recommended as an effective approach to post fracture care,

to improve both the diagnosis and the management of osteoporosis.

Following a fragility fracture, an educational initiative should be targeted at both the patient and the primary care physician.

Point-of-care tools and other targeted strategies are recommended to support the implementation of osteoporosis guidelines in clinical practice.

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Appendix C

2010 Osteoporosis Canada Clinical Practice Guidelines - Endorsements

Osteoporosis Canada’s 2010 Clinical Practice Guidelines for the Diagnosis and Management of Osteoporosis of Canada have been endorsed by the following professional organizations:

Canadian Association of Physician Assistants

Canadian Association of Radiologists

Canadian Chiropractic Association

Canadian Orthopaedic Association

Canadian Osteopathic Association

Canadian Panel of the International Society for Clinical Densitometry

Canadian Pharmacists Association

Canadian Rheumatology Association

Canadian Society of Endocrinology and Metabolism

Dietitians of Canada

Nurse Practitioners’ Association of Ontario

Society of Obstetricians and Gynaecologists of Canada

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Appendix D

Acknowledgements

This document was made possible through the commitment and contributions of dedicated volunteers at Osteoporosis Canada. We wish to thank these many volunteers for their hard work in guiding and preparing this report. WHITE PAPER COMMITTEE David Cudmore, MD, Antigonish, Nova Scotia Larry Funnell, Chair, Canadian Osteoporosis Patient Network, Surrey, British Columbia Janet Gordon, MD, Halifax, Nova Scotia Marg MacDonell, National Advocacy Co-Chair, Lorette, Manitoba Victoria Mitchell, MD, Halifax, Nova Scotia Irene Polidoulis, MD, Toronto, Ontario Diane Thériault, MD, National Advocacy Co-Chair, Dartmouth, Nova Scotia Anne Marie Whelan, PharmD, Halifax, Nova Scotia SCIENTIFIC ADVISORY COUNCIL REVIEW COMMITTEE Stephanie Kaiser, MD, Halifax, Nova Scotia Anthony Hodsman, MD, London, Ontario Bill Leslie, MD MSc, Winnipeg, Manitoba Suzanne Morin MD MSc, Montreal, Quebec Alexandra Papaioannou MD MSc, Hamilton, Ontario

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 33.   Reginster J, Minne HW, Sorensen OH et al. Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. Osteoporos Int 2000;11(1):83‐91. 

 34.   McClung MR, Geusens P, Miller PD et al. Effect of risedronate on the risk of hip fracture in elderly women. Hip Intervention Program Study Group. N Engl J Med 2001;344(5):333‐340. 

 35.   Watts NB, Josse RG, Hamdy RC et al. Risedronate prevents new vertebral fractures in postmenopausal women at high risk. J Clin Endocrinol Metab 2003;88(2):542‐549. 

 36.   Roux C, Seeman E, Eastell R et al. Efficacy of risedronate on clinical vertebral fractures within six months. Curr Med Res Opin 2004;20(4):433‐439. 

 37.   Black DM, Delmas PD, Eastell R et al. Once‐yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med 2007;356(18):1809‐1822. 

 38.   Lyles KW, Colon‐Emeric CS, Magaziner JS et al. Zoledronic acid and clinical fractures and mortality after hip fracture. N Engl J Med 2007;357(18):1799‐1809. 

 39.   Cummings SR, San MJ, McClung MR et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med 2009;361(8):756‐765. 

 40.   Neer RM, Arnaud CD, Zanchetta JR et al. Effect of parathyroid hormone (1‐34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med 2001;344(19):1434‐1441. 

 41.   Ettinger B, Black DM, Mitlak BH et al. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3‐year randomized clinical trial. Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators. JAMA 1999;282(7):637‐645. 

 42.   Pols H, Eastell R, Delmas P, et al. Early onset and sustained efficacy of raloxifene on incident vertebral fractures in postmenopausal women with osteoporosis: 4‐year results from MORE trial. Bone 28[Suppl], S85. 2001.  

 43.   McLellan AR, Gallacher SJ, Fraser M, McQuillian C. The fracture liaison service: success of a program for the evaluation and management of patients with osteoporotic fracture. Osteoporos Int 2003;14(12):1028‐1034. 

 44.   Bogoch ER, Elliot‐Gibson V, Beaton DE, Jamal SA, Josse RG, Murray TM. Effective initiation of osteoporosis diagnosis and treatment for patients with a fragility fracture in an orthopaedic environment. J Bone Joint Surg Am 2006;88(1):25‐34. 

 45.   Sander B, Elliot‐Gibson V, Beaton DE, Bogoch ER, Maetzel A. A coordinator program in post‐fracture osteoporosis management improves outcomes and saves costs. J Bone Joint Surg Am 2008;90(6):1197‐1205. 

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 46.   Majumdar SR, Johnson JA, Lier DA et al. Persistence, reproducibility, and cost‐effectiveness of an intervention to improve the quality of osteoporosis care after a fracture of the wrist: results of a controlled trial. Osteoporos Int 2007;18(3):261‐270. 

 47.   Majumdar SR, Beaupre LA, Harley CH et al. Use of a case manager to improve osteoporosis treatment after hip fracture: results of a randomized controlled trial. Arch Intern Med 2007;167(19):2110‐2115. 

 48.   Morrish DW, Beaupre LA, Bell NR et al. Facilitated bone mineral density testing versus hospital‐based case management to improve osteoporosis treatment for hip fracture patients: additional results from a randomized trial. Arthritis Rheum 2009;61(2):209‐215. 

 49.   Dell R, Greene D, Schelkun SR, Williams K. Osteoporosis disease management: the role of the orthopaedic surgeon. J Bone Joint Surg Am 2008;90 Suppl 4:188‐194. 

 50.   Greene D, Dell RM. Outcomes of an osteoporosis disease‐management program managed by nurse practitioners. J Am Acad Nurse Pract 2010;22(6):326‐329. 

 51.   Boire G, Beaulieu M, Lambert D, Cabana F. The OPTIMUS intervention: Primary Care Practitioners treating osteoporosis in up to 64% of patients with fragility fracture. J Bone Miner Res 24[Suppl 1]. Available at http://www.asbmr.org/Meetings/AnnualMeeting/AbstractDetail.aspx?aid=e1ed0ab6‐2df2‐4277‐a9dd‐f45cd94400e4.  Accessed March 2, 2011.  

 52.   Majumdar SR, Lier DA, Beaupre LA et al. Osteoporosis case manager for patients with hip fractures: results of a cost‐effectiveness analysis conducted alongside a randomized trial. Arch Intern Med 2009;169(1):25‐31. 

 53.   Dell R, Greene D. Is osteoporosis disease management cost effective? Curr Osteoporos Rep 2010;8(1):49‐55. 

 

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Osteoporosis Canada is the only national organization serving people who have or are at risk for osteoporosis. Consult our website at www.osteoporosis.ca for the most up to date information.

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